REG - Polarean Imaging PLC - Oxford research collaboration in long COVID

Polarean ImagingAnnouncement

11/05/2022 07:00

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RNS Number : 0194L  Polarean Imaging PLC  11 May 2022

Polarean Imaging Plc

("Polarean" or the "Company")

 

Research collaboration with Oxford University Hospitals for long COVID

EXPLAIN study will evaluate the underlying causes of persistent breathlessness
in patients with long COVID using hyperpolarised xenon MRI

 

Polarean Imaging plc (AIM: POLX), the medical‑imaging technology company,
with an investigational drug‑device combination product using hyperpolarised
(129)xenon gas to enhance magnetic resonance imaging (MRI) in pulmonary
medicine, and Oxford University Hospitals NHS Foundation Trust ("OUH")
announce that they have entered into a research collaboration to study the
long-term effects of COVID-19 in patients who are still experiencing
difficulty breathing months after the virus infection is gone, as part of the
upcoming EXPLAIN study.

 

Under the terms of the collaboration, Polarean will provide its
investigational xenon polariser system to OUH for their research. In turn, OUH
will work with Polarean to optimise the imaging workflow and analyse the
datasets coming from the newly enrolling EXPLAIN study. Through novel analyses
of gas-exchange images, Polarean and OUH hope to better characterise long
COVID and improve patient care.

 

(129)Xenon MRI imaging technology uses a novel approach that can detect
functional changes of the lung that impact its ability to properly handle the
exchange of gases during inhalation and exhalation. The upcoming research
builds upon the pioneering work conducted at OUH showing that hyperpolarised
xenon MRI can detect underlying damage that is not detectable by traditional
lung imaging, such as CT scans.

 

Prof Fergus Gleeson, Professor of Radiology at the University of Oxford and
Consultant Radiologist at OUH, said: "We are pleased to be working with
Polarean, now having access to their most advanced hyperpolarised xenon
equipment. With this new system, we will be able to image increased numbers of
patients more efficiently to see if we can uncover the underlying causes
driving long COVID as part of our EXPLAIN study."

 

Richard Hullihen, CEO of Polarean, said: "Oxford University is a leading
pioneer in the use of (129)Xe MRI to unravel the underlying pathophysiology
that drives persistent breathlessness in patients with long COVID. We are
delighted to collaborate with them on new image analyses as part of the
upcoming EXPLAIN trial that might shed additional light on the mysterious
illness that has been affecting a growing number of patients over the past few
years and affecting their quality of life."

 

Enquiries:

 

 Polarean Imaging plc                                     www.polarean.com / www.polarean-ir.com
 Richard Hullihen, Chief Executive Officer                Via Walbrook PR
 Ken West, Chairman

 Stifel Nicolaus Europe Limited (NOMAD and Sole Corporate Broker)            +44 (0)20 7710 7600
 Nicholas Moore / Samira Essebiyea / William Palmer-Brown (Healthcare
 Investment Banking)
 Nick Adams / Fred Walsh (Corporate Broking)

 Walbrook PR        Tel: +44 (0)20 7933 8780 or polarean@walbrookpr.com
 Paul McManus / Anna Dunphy            Mob: +44 (0)7980 541 893 / +44 (0)7879 741 001

About long COVID

Long COVID is an umbrella term used to describe ongoing symptoms following
COVID-19 infection after four weeks. Symptoms are wide-ranging but
breathlessness is one of the most common and can persist for months after the
initial infection. Investigations including Computed Tomography (CT) and
physiological measurements (lung function tests) can often be unremarkable.
The mechanisms driving breathlessness remain unclear, and this may be
hindering the development of effective treatments. Therefore, new diagnostic
modalities are crucial to advance the care of these patients.

 

About hyperpolarised Xe MRI

A polarisation device transforms the inert noble gas, (129)xenon, into a
hyperpolarised state using circularly polarised laser light. The
hyperpolarised gas is inhaled by a patient to fill the space normally occupied
by air in a single 10-second breath hold. The hyperpolarised gas then enhances
the MRI signal, making regional lung function, including gas exchange, from
the lungs to the blood visible in an MRI scan. The use of xenon MRI is
non-invasive, and does not impart any radiation to the patient.

 

About the EXPLAIN Clinical Study

The EXPLAIN study, which involves teams in Oxford, Sheffield, Cardiff and
Manchester, is using hyperpolarised xenon MRI scans to investigate possible
lung damage in long COVID patients who have not been hospitalised with
COVID-19 but who continue to experience breathlessness.

It is envisaged that 400 participants will be recruited. These include:

 

§ Patients diagnosed with long COVID, who have all been seen in dedicated
long COVID clinics and who have normal CT scans

§ Participants who have been in hospital with COVID-19 and discharged more
than three months previously, who have normal or nearly normal CT scans and
who are not experiencing long COVID

§ An age- and gender-matched control group who do not have long COVID
symptoms and who have not been hospitalised with COVID-19

 

The findings of an initial pilot study involving 36 people has identified
abnormalities in the lungs of long COVID patients who had been experiencing
breathlessness.

 

About Polarean (www.polarean.com)

The Company and its wholly owned subsidiary, Polarean, Inc. (together the
"Group") are revenue-generating, investigational drug-device combination
companies operating in the high-resolution medical imaging research space.

 

The Group develops equipment that enables existing MRI systems to achieve an
improved level of pulmonary function imaging and specialises in the use of
hyperpolarised Xenon gas ((129)Xe) as an imaging agent to visualise
ventilation. (129)Xe gas is currently being studied for visualisation of gas
exchange regionally in the smallest airways of the lungs, across the alveolar
tissue membrane, and into the pulmonary bloodstream.

 

In October 2020, the Group submitted a New Drug Application ("NDA") to the FDA
for hyperpolarised (129)Xe used to evaluate pulmonary function and to
visualise the lung using MRI. The Group received a complete response letter on
5 October 2021. On 30 March 2022, the Company filed the resubmission of its
NDA with the US FDA and has received a PDUFA date of Sept 30, 2022.

The Group operates in an area of significant unmet medical need and the
Group's technology provides a novel investigational diagnostic approach,
offering a non-invasive and radiation-free functional imaging platform.

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